Compression device with wear area

ES 2 554 539 T3

DESCRIPTION

Compression device with wear zone

Field of the invention

The present invention relates generally to a compression device for applying compression therapy to a part of the body of a user.

Background of the invention

A major concern for immobile patients and others alike is medical conditions that form blood clots, such as deep vein thrombosis (DVT) and peripheral edema. Such patients and people include those undergoing surgery, anesthesia, long periods of bed rest, etc. In general, these blood clotting conditions occur in the deep veins of the lower extremities and / or the pelvis. These veins, such as the iliac, femoral, popliteal, and tibial, return deoxygenated blood to the heart. For example, when blood flow in these veins is delayed due to illness, injury, or inactivity, there is a tendency for blood to pool or pool. A static pool of blood is ideal for clot formations. A major risk associated with this state is interference with cardiovascular circulation. Most seriously, a piece of the blood clot can break off and migrate. A pulmonary embolism can form a blockage in a main pulmonary artery, which can be life-threatening.

The conditions and the resulting risks associated with the immobility of the patient can be controlled or alleviated by applying intermittent pressure to a limb of a patient, such as, for example, a leg to aid in blood circulation. Known devices have been used to aid blood circulation, such as one-piece pads and compression boots. See, for example, US Patent Nos. 6,290,662 and 6,494,852.

For example, sequential compression devices have been used, consisting of an air pump connected to a disposable wrap pad via a series of air tubes. The wraparound pad is placed around the patient's leg. The air is then sequentially forced into different parts of the wrap pad, acting as a peristaltic pump on the leg and enhancing venous return. Document US 2008/234615 A1 further discloses a compression device with fasteners of limited durability provided with means to control the degradation of the closing strength of the fastener. This control is based on contamination of the adhesive tab by a contrasting color.

Summary of the invention

In one aspect of the present invention as defined in claim 1, a device for applying a compression treatment to a body part of the user has an inner face to be positioned adjacent to the body part of the user during use and an outer face opposite the inner face. The device generally comprises a pressure applicator for applying compression to the body part of the user when the device is positioned on the body part of the user. A first clamping element is mounted on the device. A second fastener is mounted on the device and is adapted to releasably connect to the first fastener for use in holding the device on the body part of the user. A visual indicator is associated with the second fastener and is adapted to show where to engage the first fastener with the second fastener. The visual indicator is adapted to wear upon repeated connection and disconnection of the first and second fasteners so that the visual indicator fades over time. The invention is characterized in that the first fastening element comprises a hook material, the second fastening element comprises a loop material having a multiplicity of loops, and the visual indicator comprises a colorant on at least a part of the loop material. , the colorant being disposed on the loops of the loop material to be less visible when the loops are broken by repeated connection and disconnection of the first and second fasteners.

[0006] In yet another aspect, as defined in claim 9, a method of manufacturing a compression device for use in applying compression to a part of the user's body generally comprises providing an applicator pressure to apply compression to the user's body part when the device is placed on the user's body part. The hook material is attached to the device. The loop material is colored in a selected area for attachment of the hook material to the loop material so that the coloration becomes less visible when the loop material and the hook material are repeatedly connected and disconnected. The loop material is attached to the device at a location for selective engagement with the hook material for use in securing the compression device to the wearer's body part.

Other advantageous features are defined in the dependent claims.

ES 2 554 539 T3

Brief description of the drawings

Figure 1 is a front elevation of a compression sleeve;

Figure 2 is an exploded perspective of the compression sleeve;

Figure 3 is a rear elevation of an inner layer of the compression sleeve;

Figure 4 is a front elevation of the compression sleeve with the outer cover removed;

Figure 5 is a longitudinal section of the compression sleeve with the inflatable chambers of the sleeve in an inflated state;

Figure 6 is a longitudinal section of the compression sleeve with the inflatable chamber in a deflated state;

Figure 7 is an enlarged fragmentary elevation of the outer shell illustrating the tie material; Figure 8 is similar to Figure 1 showing discolored hook engagement areas; and Figure 9 is an enlarged, fragmented front elevation of the compression sleeve with distal fins attached to an outer face of the sleeve. Corresponding reference characters indicate corresponding parts throughout the drawings.

Detailed description of the drawings

Referring now to the drawings, and in particular to Figures 1 and 2, an embodiment of a compression device (broadly speaking, "a garment or a sleeve") is indicated at 10 for applying a compression therapy. sequential compression to a limb of a user. The compression sleeve is of the type sized and shaped to fit around a wearer's leg, but could be configured for application to other parts, including in particular the appendages, of the wearer's body. More specifically, the sleeve 10 has a width W (FIG. 1) to wrap around a full circumference of the leg and a length L (FIG. 1) to run from the ankle to a thigh of the leg. It will be understood that a compression sleeve can come in different sizes, such as a knee length sleeve (figure 8) that extends from the ankle to the calf of the leg. It is understood that other types of compression devices to be arranged around other parts of the wearer's body (eg, the foot), are within the scope of this invention, such as a wrap around the chest of a patient in the treatment of cancer. breast.

A numerical study by RD Kamm, entitled "Bioengineering Studies of periodic Exteriorl Compression as Prophylaxis Against Deep Vein Thrombosis - Part I: Numerical Studies" concluded, among other things, that "the entire length of the veins should be emptied completely and as quickly as possible. possible". The Kamm study reviews three types of compression, the one of greatest interest is compression in the form of waves. Waveform compression is very similar to the sequential compression provided by the illustrated embodiments of the present invention. The Kamm study found that waveform compression is most effective on moving blood during effective prophylaxis treatment.

Referring to Figures 1 and 2, compression sleeve 10 comprises four layers attached to each other in the illustrated embodiment of the present invention. The scope of the present invention is not limited to the four layers. More specifically, the compression sleeve comprises an inner layer, generally indicated 12, on which is superimposed a first intermediate layer (broadly, a first chamber layer), generally indicated 14. A second intermediate layer (in the broad sense, a second chamber layer), generally indicated 16, which is superimposed on and attached to the first intermediate layer 14. An outer cover generally indicated 18, which overlaps and attaches to the second intermediate layer 16. During operation, the inner layer 12 is disposed more adjacent to the wearer's limb and is in contact with the wearer's limb, and the outer cover 18 is more distant from the wearer's limb. A knee opening 19 is formed through the sleeve 10 that is generally aligned with the back of the knee when the sleeve is applied to the leg. The layers have the same geometric shape and are superimposed on each other so that the edges of the layers generally coincide. It is contemplated that one or more of the layers 12, 14, 16, or 18 cannot be superimposed on a corresponding layer, but is shifted slightly to accommodate a particular feature of a patient's limb. On the other hand, the number of sheets or thickness that constitutes each layer 12, 14, 16, or 18 of the compression sleeve 10 may be different from that described. The thickness of the layers can be varied to add strength or cause further expansion in one direction, eg towards the limb, during inflation.

Referring to Figures 1, 2 and 4, each of the first and second interlayers 14, 16, respectively, includes a single sheet of elastic material (broadly, "chamber material"). For example, sheets 14 and 16 are made of a flexible PVC material as the chamber material. Layers 12 and 18 are made of a polyester material. The second intermediate layer 16 is attached to the first intermediate layer 14 through three separate chamber seam lines 22a, 22b, 22c that define a proximal chamber 24a, an intermediate chamber 24b, and a distal chamber 24c, respectively, which are spaced apart. longitudinally along the sleeve 10. The number of chambers may be other than three without departing from the scope of the present invention. As used herein, the terms "proximal," "distal," and "intermediate" represent relative locations of components, parts, and the like of the compression sleeve when the sleeve is attached to the limb of the wearer. As such, a "proximal" component or the like is disposed more adjacent to a

ES 2 554 539 T3 point of attachment of the limb of the user to the torso of the user, a "distal" component is arranged more distant from the point of attachment, and an "intermediate" component is generally arranged anywhere between the components. proximal and distal.

For reasons discussed below, the proximal chamber 24a defines a proximal lateral extension 25 near the margin of the upper edge of the sleeve 10. The chambers 24a, 24b, 24c are circumferential chambers which means they are dimensioned and shaped to substantially wrap around the entire circumference of the wearer's limb or almost the entire circumference of the limb. For example, in one embodiment each of the chambers 24a, 24b, 24c extends around at least 90% of a median circumference of a leg. However, prior art devices have partial chambers such as Aircast ® and HillRom ®, and these prior art devices do not contemplate the openings, elasticity and other features of the present invention. It should be understood that the construction described herein can be adopted by prior art sleeves with a partial chamber construction, without departing from the scope of the present invention.

Intermediate layers 14,16 can be attached to each other by radio frequency welding, an adhesive, or other chemical and / or mechanical process. It is understood that the interlayers 14, 16 may be attached to each other at other locations such as around their peripheries and at chamber seam lines 22a, 22b, 22c to further define the shape of inflatable chambers 24a, 24b, 24c. For the purposes discussed below, the first intermediate layer 14 is attached to the inner layer 12 along a seam line 25 (Figures 5 and 6) that runs along the outer periphery of the first intermediate layer 14 of so that the central regions of the chambers 24a, 24b, 24c are not attached to the inner layer 12. This allows the chambers 24a, 24b, 24c to move relative to the inner layer 12. The second intermediate layer 16 may also be attached to the inner layer 12 along the same seam line 25. The first intermediate layer 14 may be attached to the inner layer 12 by RF welding or an adhesive or in other ways. adequate. This structure improves comfort, as described below.

Referring to Figures 2 and 4, each inflatable chamber 24, 24b, 24c receives a fluid from a compressed fluid source (not shown) through a dedicated proximal chamber tube 26a, an intermediate chamber tube 26b, and a distal chamber tube 26c, respectively, (Figure 2). It is not necessary to dedicate a tube line to a chamber to practice the invention. Each tube 26a, 26b, 26c is arranged between the intermediate layers 14, 16 and attached to the respective chamber 24a, 24b, 24c by the respective chamber seam line 22a, 22b, 22c. As best shown in Figures 2 and 4, the first intermediate layer 16 defines a cutout 27 (Figure 2) such that the tube portions 26a, 26b, 26c are not disposed between the intermediate layers. Other ways of attaching tubes 26a, 26b, and 26c to chambers 24a, 24b, and 24c are within the scope of the invention. The opposite ends of tubes 26a, 26b, and 26c are grouped together using a second connector 30 (Figures 1 and 2) that is adapted to fluidly connect the tubes to the source of the compressed fluid. The source of compressed fluid can be an air compressor under the control of a microprocessor that sequentially pressurizes the chambers as is generally known in the art. An exemplary air compressor is described in Bock US Patent No. 5,876,359. Chambers 24a, 24b, 24c may be configured to contain pressurized air to at least about 10 mm Hg (1333 Pa) to about 45 mm Hg (6000 Pa). The chambers should be capable of being repeatedly pressurized without failure. Suitable materials for the sheets include, but are not limited to, a flexible PVC material that does not substantially stretch. In another embodiment, the intermediate layers may form a chamber to receive an inflatable chamber that is formed separately from the chamber. In this embodiment, the layers may not be able to hold pressurized air for as long as the inflatable chambers are capable of. It will be appreciated that chambers 24a, 24b, 24c may have openings 32 that extend completely through the chambers, as described in embodiments of the present invention.

Referring specifically to Figures 1 and 4, sleeve 10 defines a connecting section that includes a pair of bridge member limbs 84 on opposite sides of knee opening 19 that extend between and connect a proximal portion of the sleeve. which includes chamber 24a proximal to the rest of the sleeve. Proximal tube 26a is generally along an axis of bridge member 84 to provide structural longitudinal support to sleeve 10. As best shown in Figure 4, cutout 27 in intermediate sheet 16 does not extend through bridge element 84. Proximal tube 26a extends between welds 86 at spaced distal points disposed adjacent to a distal end of the element. bridge 84 and between spaced proximal spot welds 88 disposed adjacent a proximal end of the bridge element. Spot welds secure tube 26a to bridge member 84 such that proximal chamber tube 26a constitutes a rigid structural component (broadly a "rigid first structural component") to maintain clearance between proximal chamber 24a. and the intermediate chamber 24b and to maintain the longitudinally structural integrity of the connecting section. In other words, the sleeve 10 becomes rigid against collapsing or sliding down the wearer's leg. As explained above, proximal chamber tube 26a is attached to proximal chamber 24a at proximal lateral extension 25. Proximal chamber tube 26a runs along one side of a distal portion of proximal chamber 24a so it does not enter the chamber until it reaches the proximal lateral extension 25. Attaching to the proximal lateral extension 25 of the chamber 24a provides additional longitudinal support to the proximal sleeve 10 because the proximal chamber tube 26a extends more longitudinally through the proximal portion of the sleeve than if the tube is clamped.

ES 2 554 539 T3 in a distal part of the chamber. In one embodiment, proximal chamber tube 26a extends at least a quarter of the way through a thigh section of sleeve 10. In another embodiment shown in Figure 4, tube 26a extends more than halfway through thigh section. This helps preserve the proximal portion of the sleeve 10 from collapsing and / or sliding into a downward position on the wearer's leg.

Referring to Figures 2 and 4, in addition to the proximal chamber tube 26a, a second rigid structural component 90, disposed between the intermediate layers 14, 16 and extending into the other bridge element 84 of the connecting section, provides also a longitudinal structural support to the sleeve 10. The second structural component 90 extends between the proximal and distal ends of the bridge member 84. The respective proximal and distal ends of the structural component 90 are wider than an intermediate portion of the component and the periphery of the component generally conforms to the peripheries of the side walls of the bridge element 84 so that the structural component is secured. to the bridge element.

Referring to Figures 3 and 4, proximal chamber 24a is secured to inner layer 12 and outer shell 18 at spot welds 92 adjacent to chamber openings 32 and within an outer perimeter of the chamber defined by the chamber seam line 22a. Spot welds 92 hold outer shell 18 and inner layer 12 in a correct position relative to chambers 24a, 24b, 24c. In other words, the spot welds 92 prevent chambers 24a, 24b, 24c from moving substantially relative to inner layer 12 and outer cover 18 while still providing sleeve 10 with substantial flexibility. Excess movement of inner layer 12 and outer shell 18 relative to chambers 24a, 24b, 24c can reduce the fit of the sleeve, thus leading to reduced effectiveness of compression therapy. Proximal chamber 24a is free from attachment to inner layer 12 and outer shell 18 other than spot welds 92 to maintain flexibility of the sleeve so that mobility of the patient's leg is not compromised. The inner layer 12 may be attached to the layer 16 at welds 86, 88, spot 92 or the inner layer 12 may be attached to the seam line 34 of the opening 32. Away from openings 32 and welds 86, 88, spot 92, the inner layer 12 is not bonded to the surface of the chamber material that forms the chamber which expands to provide a compression treatment to the limb of the patient.

In one embodiment, chambers 24a, 24b, 24c are constructed to expand more toward the user than away from the user, thereby applying a greater compressive force to the limb of the user. In one example, the first intermediate layer 14 (ie, the layer most adjacent to the inner layer 12) has a thickness less than that of the second intermediate layer 16. With both layers 14, 16 being of the same material (ie an elastic PVC material) the first intermediate sheet will have a lower modulus of elasticity. Thus, when air is introduced into the chambers 24a, 24b, 24c, the chambers will expand more towards the inner layer 12 and towards the user than away from the user. It is understood that other ways, in addition to a difference in thickness between the intermediate layers 14, 16, of the construction of the chambers 24a, 24b, 24c so that these expand more towards the user than away from the user, is within the scope of the invention.

Referring to Figures 2 and 3, the inner layer 12 is constructed of a material that is capable of absorbing moisture near an extremity of the patient. It is understood that the inner liner 12 may be of other configurations, may have other characteristics and properties, and may be formed from another material described below. The inner layer 12 (or "absorbent"), through capillary action, absorbs moisture trapped near the wearer's leg or limb, carries moisture away from the surface of the limb, and carries moisture from locations in the end in the inner layer 12 in which the humidity is abundant to the areas in which it is less abundant, in the openings 32, for its evaporation to the ambient environment. The openings can be of various sizes, shapes, and locations within the area of ​​the chamber that provides compression. An opening 32 exposes the absorption layer to ambient or surrounding air as opposed to the portion of the absorption layer below the chamber material. The parts of the inner layer 12 in registration with the openings 32 may be referred to as "exposed parts." Other ways of exposing the absorption material are within the scope of this invention, such as slits or extending the absorption material outside the perimeter of the chamber material. The present invention has its exposed portion within the chamber area that provides compression. The compression zone is the zone of the chamber that expands and contracts under the influence of air pressure or other fluids. The zone of the chamber that does not provide compression is the seam line or the weld points which are points of the chamber material sealed together to provide an air-tight or watertight boundary or other regions of the opposing sheets 14, 16 outside the perimeter of the chamber. The absorbent material 12 can be interwoven with the impermeable material to form the inner layer 12. The absorbent material 12 transports the moisture to an area of ​​less moisture. The openings 32 should be designed to maintain the velocity of the blood, while maximizing the evaporation of moisture. Suitable absorption materials can be composed of, for example, some form of polyester, although they can be composed of polypropylene. Microfibers can be used. Suitable microfiber materials include, but are not limited to, a CoolDry model number CD9604, sold by Quanzhou Fulian Warp Industrial Co., Ltd., of Quanzhou City, Fujian Province, China, and a CoolMax®, sold by EI du Pont de Nemours and Company, Wilmington, Delaware.

The construction of the absorption layer, the openings, the chamber and the outer layer are covered. The openings must

ES 2 554 539 T3 be sized and shaped to maintain the blood flow efficiency of a compression sleeve such as the Model 9529 and to provide enhanced moisture evaporation to increase patient compliance. Referring to Figures 1 and 4, the sleeve 10 is constructed so that the parts of the intermediate layers 14, 16 do not overlap the inner layer 12 so that the moisture absorbed by the inner layer 12 moves to the parts opening of the inner layer 12 and evaporates to the atmosphere. In this illustrated embodiment, each inflatable chamber 24a, 24b, 24c includes openings 32 that extend, through the first and second intermediate layers 14, 16, respectively, into the inner layer 12. One way of forming such an opening is to sealing the intermediate layers 14, 16 together within the periphery of the respective chamber 24a, 24b, 24c using a continuous seal line 34. Portions of intermediate layers 14, 16 within a periphery of seal line 34 may be removed, such as by cutting, thereby forming apertures 32. Other ways of forming apertures 32 are within the scope of this invention. Once the size and pattern of an opening is determined, a metal die is used to cut the openings in the PVC chamber material from the opposing sheets.

For the preferred embodiment, the shape of the opening is generally formed like a drop of water. Each opening 32 is tapered from a first rounded end portion to a second smaller rounded end portion. The openings 32 can be of other shapes, such as circles, ovals, and slits, without departing from the scope of the invention. The aperture shapes can be intermixed in the chamber without departing from the scope of the invention.

With respect to each chamber 24a, 24b, 24c, the openings 32 are arranged in a distal row 36 and a proximal row 38 (Figure 4). Both rows 36, 38 extend through the respective chamber 24a, 24b, 24c along the width W of the sleeve 10. As shown in the drawings, the openings 32 of each proximal row 38 are half-inverted raindrop-shaped openings in which the openings taper distally, while the openings of each distal row 36 are right-side-facing openings. above where the openings taper in the proximal direction. The openings 32 in each distal row 36 are offset along the width W of the sleeve from the openings in the respective proximal row 38. The displacement of the apertures 32 distributes the apertures evenly across the surface area of ​​the chambers 24a, 24b, 24c, thereby increasing the breathability of the chambers and the overall breathability of the sleeve 10 without compromising the structural integrity of chambers or their ability to apply a compressive force (i.e. prophylactic treatment) to the leg or a part of the body. On the other hand, the displacement of the openings in the respective distal and proximal rows 36, 38, also makes the chambers 34a, 34b, 34c more stretchable in the transverse direction of the sleeve 10. Other ways to allow the fluid absorbed by the inner layer 12, in addition to the openings 32 through the chambers, are within the scope of the invention.

Referring to Figures 1 and 2, the outer cover 18 of the compression sleeve 10 is constructed of a single sheet of material. The outer shell 18 is breathable and has a multiplicity of openings 40 or perforations such that it has a mesh construction to provide even more breathability. It is understood that the outer cover 18 can be of other configurations, can have other characteristics and properties, and can be formed from another material that is described below. A suitable material for the outer cover 18 can be a polyester mesh. The evaporation rate of the apertures is improved by treating the fibers of the mesh material with a hydrophilic material. The mesh material will absorb absorbent fluids more easily. Absorbent fibers of this type are generally indicated at 21 in Figure 7. These hydrophilic fibers reduce the surface tension of the mesh material to allow body fluids to be more easily absorbed into the fibers and dispersed through the fibers. same for a more efficient evaporation of the absorbent fluid. Absorbing the fluid more easily will allow the fluid to move to open areas more quickly for evaporation. The capillary effect becomes more efficient when the fluid absorbed in the openings moves faster through the outer mesh cover 18.

Referring to Figures 1, 5 and 6, the outer cover 18 is attached to the second intermediate layer 16 along the seam line 42, which runs only adjacent to the outer periphery of the second intermediate layer so that the chambers 24a, 24b, 24c are free from attachment to the cover. The second intermediate layer 16 can be attached to the inner layer 12 by RF welding or an adhesive or in other suitable ways.

Referring to Figures 1 and 7, the entirety of an outer surface of the outer cover 18 also acts as a fastening component of a fastening system to secure the sleeve 10 to the limb of the user. In a particular embodiment, the outer mesh cover 18 (Figure 7), for example, has an outer surface comprising loops 44 (Figure 7) that act as a loop component of a hook and loop fastening system. A mesh construction, as shown in Figure 7, has interconnected the woven fibers 21 of the material that forms the outer shell 18. The loops 44 may be formed as part of the material of the outer shell 18 or otherwise arranged on the surface. of the outer cover. A suitable material with such a construction is a 2103 polyester mesh loop sold by Quanzhou Fulian Warp Industrial Co., Ltd. of Quanzhou City, China. Hook components 46 (FIG. 3) are attached to an inner surface of inner layer 12 at proximal, intermediate, and distal flaps 41a, 41b, 41c, respectively. The loops 44 of the outer cover 18 allow the hook components 46 (Figure 3) to be attached anywhere along the outer surface of the outer cover when the sleeve 10 is circumferentially wrapped around the sleeve.

ES 2 554 539 T3 limb of the user. This allows a sleeve 10 to be substantially of a one-size-fits-all configuration with respect to the circumferences of the different limbs of the wearers. Furthermore, the outer cover 18 having the loops 44 allows the physician to quickly and confidently attach the sleeve 10 to the limb of the user without the need to align the attachment components.

The hook components 46 (generally speaking the first fasteners) can be attached anywhere along the outer surface of the sleeve 10 (for example, on the outer cover 18), but the hook engagement areas 100 colored ones are printed using a colorant, such as ink or dye, on an outer surface of the outer cover to indicate to the user where the hook components 46 should be attached. This can ensure proper alignment of the sleeve 10. In the illustrated embodiment, there are three hook engagement zones 100 (broadly, the visual indicators) that indicate where each of the three corresponding hook components 46 should be attached on the outer surface of the outer cover 18. The outer cover 18 is formed of or includes a loop material that can be considered broadly as a second fastener. Each hook engagement area 100 comprises a selected area of ​​loops that are a different color (eg, blue) than a color of the loops (eg, white) in an adjacent area of ​​the outer surface of the outer shell 18 Each hook engagement area 100 is also a different color from the outer surface of the outer shell below the loops. In the illustrated embodiment, each hook engagement zone 100 is a generally oblong or racetrack-shaped zone extending generally transversely of the longitudinal axis of the sleeve 10, generally along the length of the sleeve 10. along the center lines of each of the three chamber sections of the sleeve 10. However, other colors, shapes and arrangements of a hook engagement zone do not depart from the scope of the present invention.

Hook markings 104 are imprinted on the outer surface of the outer cover 18 to indicate to the user the location of the hook component 46 on the inner face of the sleeve. In the illustrated embodiment, the hook markings 104 comprise three colored hook zones (eg, blue) overlaying the respective one of the three male fastening components 46. The three colored hook zones are of a different color than the rest of the outer face that is located outside of the hook engagement zone 100, and in one embodiment, the hook markings are the same color as the hook engagement zone. hook. Each of the hook markings 104 is generally in the shape of a semi-circle. Referring to Figure 9, after wrapping the sleeve 10 around the leg and fixing the hook components 46 in the respective hook engagement zones 100, each hook mark and the corresponding hook engagement zone together form a combined shape. which is either oblong or in the shape of a race track, or a circle. By forming a shape through the connection of the hook component 46 in the hook engagement zone 100 that is essentially the same as the original hook engagement zone, the user can be assured that the sleeve 10 has been placed in the leg, generally in a tight and aligned configuration. As can be understood, the size of the combined shape directly correlates to the size of a longitudinal opening formed by the wrapped sleeve 10 such that the user is able to determine an appropriate fit of the sleeve on the patient's leg. It is understood that hook engagement areas 100 and hook markings 104 may have other shapes and colors within the scope of the present invention, including other shapes in combination. On the other hand, each hook engagement zone 100 may have a different color. It is also understood that a tie component with colored ties can be formed separately from the outer shell and attached to the outer surface of the outer shell using adhesives or in other ways.

During the unbuttoning of the sleeve 10, that is, when the hooks of the hook components 46s separate from the colored loops 21 in the hook engagement zone 100, the fibers that form the loops are believed to break and / or the colorant (eg ink) on the ties is removed. As these fibers break down and / or dye is removed, they expose areas along the underside of the outer shell 18 that are not colored or have a different color than the loops (eg, white). In effect, the repeated attachment and unfastening of the hooks and loops 21 break the colored loops in the hook engagement areas 100 and / or remove the colorant from the hook engagement areas so that the general colors of the areas Hook coupling devices appear to fade and / or actually fade, as illustrated in Figure 8. It is believed that although the color of each individual loop does not fade when the loops are broken, it appears that the overall color of the hook engagement areas 100 does fade. The color of the loops is believed to actually fade when the colorant is being removed by pulling the hook components 46 away from the colored loops 21. Faded appearance and / or actual fading correlates with decreased clamping force of hook and loop fasteners, but more generally, this actual fading and / or fading appearance indicates to the user that the device compression device 10 is nearing the end of its life cycle and needs to be replaced with a new compression device. It should be understood that the fading appearance and / or the actual fading characteristic can be used with devices other than the compression device 10.

It is contemplated that the outer shell 18 may be capable of absorbing fluid in addition to being breathable. For example, the outer cover 18 can be constructed of the same material as the inner layer 12 (eg, dry and cool). In this way, the moisture absorbed by the inner layer 12 can be absorbed by the outer cover 18 through the openings 32 in the chambers 24a, 24b, 24c. The moisture is then dispersed so

ES 2 554 539 T3 uniform across the outer cover 18 and is able to evaporate more easily than if the outer cover were not formed of an absorbent material because a larger surface area of ​​the outer cover, as opposed to the inner layer 12, is exposed to the air. Alternatively, the cover may have an absorbent material placed on or on top of the outer layer.

The compression sleeve 10 as a whole is more comfortable to wear due to the synergistic relationship of layers 12, 14, 16, 18. For example, the inner layer 12 is able to absorb moisture from the limb and allow moisture to evaporate out of the sleeve 10. As noted above, absorption involves transporting moisture away from the limb and moving moisture from locations where it is abundant and transporting it to areas where it is less abundant. The material decreases its absorption rate when the moisture is distributed equally in the absorbent material and when the absorbent material is saturated. However, the breathability of the sleeve 10 allows absorbed moisture to evaporate. The water droplet apertures 32 in the chambers 24a, 24b, 24c and in the breathable outer shell 18 allow moisture in the inner layer 12 that is adjacent to the apertures to evaporate through the apertures. Consequently, when moisture evaporates, it is transported to the drier parts of the inner layer 12, and the inner layer is able to absorb more moisture.

To improve patient mobility, the sleeve is designed to have an elastic inner layer 12 and an outer cover 18. An elastic sleeve improves comfort which increases patient compliance. Reference is made to Figures 1-7 to discuss elasticity below. An elastic device will conform to the patient's limb to ensure continuous absorption. A flexible or substantially conformable fit will help ensure contact of the camera against a patient's skin during use. The chamber applies pressure to move the blood. The elastic outer layer helps reduce the number of straps to hold the sleeve in place because the elastic outer layer 18 returns to its original shape by exerting a slight force against the limb of the patient. This force helps keep the sleeve in place and also allows the practitioner not to over-tighten a strap. Some prior art devices use an elastic stocking, such as the TED ® stocking, under the compression sleeve. The compression sleeve of at least some embodiments avoids the two-step process of first placing the compression stocking on the patient, then placing the sleeve over the stocking. Also, the sleeves of the preferred embodiments of the present invention simplify the work of nurses because there is no need to order a stocking and a sleeve.

Applicant has devised an elasticity test to determine the amount of stretch around the limb and along the limb. A patient needs to move during treatment. Sleeves of the prior art can be uncomfortable, stiff, and heavy so the user would dispose of the device, should he need to move. The need is to improve elasticity without distorting the openings 32 too much such as becoming elongated or causing an opening to be covered, reducing their size for evaporation.

For example, the inner layer 12 may preferably stretch elastically along the width W of the sleeve 10 so that the inner layer is able to circumferentially conform to the shape of the wearer's limb. The circumferential fit allows the inner layer 12 to remain in close, intimate and continuous contact with the wearer's limb to ensure that the inner layer is continuously absorbing moisture from the limb. The inner layer 12 can also stretch the length L. Preferably, the inner layer 12 can stretch elastically along the width W and the length L of the sleeve and can stretch more elastically along the length. of the sleeve 10 than along the width. Summarizing the preferred approach, which uses the test described below, the inner layer 12 may have an average elasticity in the cross direction of the sleeve of between about 13 lbs / in (23 N / cm) and about 14 lbs / in (25 N / cm), and in one embodiment has an elasticity of about 13.3 lbs / in (23.3 N / cm). The inner layer 12 may have an average elasticity in the longitudinal direction of the sleeve of between about 0.5 lbs / in (0.9 N / cm) and about 0.7 lbs / in (1.2 N / cm), and in one embodiment it has an elasticity of about 0.63 lbs / in (1.10 N / cm). The small openings 20 in the inner layer 12 also allow the inner layer to stretch further.

The outer cover 18 can stretch elastically along the length L of the sleeve 10 or it can stretch both longitudinally and transversely (circumferentially). Preferably, the outer cover 18 is more elastic longitudinally than transversely. Although it can be elastically stretched, the outer cover 18 acts to restrict the amount of expansion of the chambers 24a, 24b, 24c. The outer cover 18 helps shape the chamber to the limb to help evenly apply pressure to move blood. For example, using the stretch test described below, the outer cover 18 can have a mean stretch in the transverse direction of between about 13 lbs / in (23 N / cm) and about 15 lbs / in (26 N / cm). , and in one embodiment it has an elasticity of about 13.6 lbs / in (23.8 N / cm). The outer cover 18 may have a mean stretch in the longitudinal direction of between about 19 lbs / in (33 N / cm) and about 22 lbs / in (39 N / cm), and in one embodiment a stretch of about 19.8 pounds / in (34.7 N / cm).

The compression sleeve 10 as a whole can be stretched longitudinally by means of the inner layer 12 which

ES 2 554 539 T3 can be stretched longitudinally, the intermediate layers 14, 16 and the outer cover 18. In addition, the sleeve 10 can be stretched slightly transversely by means of the capabilities of the inner layer 12, the intermediate layers 14, 16 and the cover 18 to stretch across. The waterdrop-shaped openings 32 and the fact that the openings are transversely offset also aid in transverse stretching.

It is common for patients who have undergone surgery to incur limb swelling. The transverse stretch of the sleeve 10 is more comfortable for patients who experience a swelling due to the stretching of the sleeve, that is, an increase in size in a circumferential manner, as the limb swells. On the other hand, the elasticity of the sleeve 10 allows the user to have more mobility of their limb and provides the practitioner with a greater degree of freedom when wrapping the sleeve around a wearer's leg. For example, using the stretch test described below, the thigh-high sleeve 10, comprising the inner layer 12, the interlayers 14, 16, and the outer shell 18 as described above, can have a medium stretch in the transverse direction of between about 22 lbs / in (39 N / cm) and about 27 lbs / in (47 N / cm), and in one embodiment a stretch of about 24.3 lbs / in (42.6 N / cm) . The compression sleeve 10 may have a mean stretch in the longitudinal direction of between about 17 lbs / in (30 N / cm) and about 22 lbs / in (39 N / cm), and in one embodiment a stretch of about 19.0 4 lbs / in (34.0 N / cm).

In another example, using the stretch test described below, a knee-length sleeve, comprising an inner layer, interlayers, and an outer shell of the same material as the thigh-length sleeve described above, can have a medium stretch in the cross direction of between approximately 22 lbs / in (39 N / cm) and approximately 27 lbs / in (47 N / cm), and an average elasticity in the longitudinal direction of between about 33 lbs / in (58 N / cm) and about 40 lbs / in (70 N / cm).

The following test (herein referred to as the "stretch test") is used to measure the elasticity of layers 12, 14, 16 and 18 and sleeve 10, both transversely and longitudinally. First, the frame clamps are attached to the frame (eg, one of layers 12, 14, 16, and 18 or sleeve 10) for testing. When testing longitudinal elasticity, the frame clamps are attached to the upper and lower edges of the frame. When testing for transverse elasticity, the frame clamps are attached to the opposite side edges of the frame. The sleeve specimen with the frame clamps attached to it is placed on a universal tensile testing machine (such as a universal testing machine manufactured by Instron® of Grove City, Pennsylvania) fixing the frame clamps to oppose the machine clamps machine. The machine should include a microprocessor that has a tensile force measurement program used to control the machine and record force and displacement measurements. Once the frame is attached to the machine, the opposing machine clamps move apart to a position that eliminates or minimizes slack in the frame. This position is the starting position for all subsequent tests. The tensile force measurement program is then executed. The displacement of the sleeve sample when the machine clamps are separated should be a uniform linear elongation and should not damage the structure. This offset is set and maintained for each repeat of the test. The test is repeated 7 times for each layer 12, 14, 16 and 18 and sleeve 10. Elasticity is calculated as force (in pounds) divided by displacement (in). An average elasticity of the 8 tests is calculated by adding the elasticity calculations for the 8 tests and dividing the sum by 8.

The sleeve, in some embodiments, is made more comfortable for the user by the fact that the inner layer 12 and the outer cover 18 are attached to the respective intermediate layers 14, 16 only adjacent to the outer peripheries of the inner layer and of the cover so that the chambers 24a, 24b, 24c are not attached directly to the inner layer and to the cover. This construction allows chambers 24a, 24b, and 24c to move independently of inner layer 12, and vice versa. Co-assigned United States Patent Application Serial No. 11 / 299,568 discloses an embodiment aimed at reducing chafing of a person's skin during use.

Thus, when sleeve 10 is wrapped circumferentially around the wearer's limb, inner layer 12 substantially conforms to the contour or shape of the limb and will remain substantially stationary against the wearer's limb when chambers 24a, 24b , 24c inflate and deflate and / or shift positions. Movement of the chambers 24a, 24b, 24c both when inflated and when deflated and displacing the positions relative to the limb can cause chafing and other discomfort to the patient if the surface of the chambers continually rubs against the limb. However, by fitting only on the outer peripheries of the intermediate layers 14, 16, the inner layer 12 creates a buffer between the chambers 24a, 24b, 24c and the limb that prevents chafing and other friction against the skin of the limb. The chambers 24a, 24b, 24c can move without causing a corresponding movement of the inner layer 12 against the skin.

When introducing elements of the present invention or the preferred embodiment (s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there is one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional items other than the items listed.

How various changes could be made in the previous constructions, products and methods, without departing from the

ES 2 554 539 T3 scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings should be construed as illustrative and not in a limiting sense.